Regulatory Affairs Specialist
Analyzed Australian TGA regulations for regulatory devices and AI-based software as Medical Device SaMD, providing strategic insights for Clinical Trial Application submissions to drive product development and ensure regulatory compliance. Designed preclinical and clinical trials as per TGA, EU, ISO 14155, Helsinki, and ICH GCP guidelines, focusing on Smart Inhaler and AI SaMD impact on respiratory disease management. Implemented patient recruitment strategies and developed regulatory documentation for compliance and market authorization. Integrated clinical trial requirements into product development with cross-functional teams, ensuring regulatory compliance and protocol adherence.